Analytical Validation Specialist
Position: Validation Engineer (Analytical Validation Specialist III/IV), Req#: LZAJP00005131
Location: Portsmouth, NH (100% Onsite)
Duration: 10+ Months Contract
Job Description:
Analytical Validation Specialist will lead validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first-time performance.
Key Accountabilities :
• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of analytical equipment.
• Drive/own the validation plans and execution of analytical equipment changes and process improvements.
• Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Own all forms of TW records including CC/CAPA/Deviations to support project completion.
• Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
• Review analytical equipment, manuals, and devise validation plans
• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
• Analytical Equipment Ownership
• Identify Quality Issues, involve stakeholders, and drive to completion/resolution
• Participate in Risk Assessments
• Review/Approve Commissioning Qualification Validation Documents
• Perform other duties as assigned.
Education and Experience:
• Bachelor of Science - Science-related discipline or relevant experience in the field
• Advanced - 5-10 years of experience
• Qualifying instruments
• Full qualification experience (IQ/OQ/PQ)
• Data Integrity
